|- candidate number||24166|
|- NTR Number||NTR5817|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-apr-2016|
|- Secondary IDs||NL53375.018.15 METC AMC|
|- Public Title||Deep brain stimulation in Parkinson's disease: general anesthesia compared to local anesthesia|
|- Scientific Title||General Anesthesia versus Local Anesthesia in Stereotaxy for Deep Brain Stimulation in Parkinsons disease: a randomized controlled trial|
|- hypothesis||We hypothesize that performing Deep Brain Stimulation (DBS) under general anesthesia will (1) further improve outcome by lessening postoperative cognitive, mood and behavioral adverse effects, (2) shorten surgery time and hospital admittance, and (3) produce comparable symptomatic and functional improvement as surgery under local anesthesia |
|- Healt Condition(s) or Problem(s) studied||Parkinson's disease, Verdoving, Deep Brain Stimulation (DBS)|
|- Inclusion criteria|| Age > 18 years; |
Idiopathic PD with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry;
Despite optimal pharmacological treatment, at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonia or bradykinesia;
A life expectancy of at least two years.
|- Exclusion criteria|| Legally incompetent adults;
Previous PD-neurosurgery (e.g., DBS, pallidotomy, thalamotomy); |
Contraindications for DBS surgery, such as a physical disorder making surgery hazardous;
Hoehn and Yahr stage 5 at the best moment during the day;
No written informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2016|
|- planned closingdate|
|- Target number of participants||110|
|- Interventions||Patients will be randomized to DBS under general anesthesia or DBS under local anesthesia. As is standard procedure, 2 electrodes will be implanted in the brain and will connected to an implanted pulse generator, which will be place subcutaneously in the subclavian area.|
|- Primary outcome||Number of patients with significant cognitive, mood and behavioral effects indicated by a stringent composite score of >1 within 6 months after surgery.|
|- Secondary outcome||MDS-UPDRS, CDRS, PDQ-39, treatment satisfaction, burden of therapy, sugery time, duration of hospital admittance, PD-medication changes, adverse effects and complications|
|- Timepoints||1) Screening (baseline)|
3) Day 1 or 2 after surgery
4) 2 weeks after surgery
5) 6 months after surgery
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Rozemarije Holewijn|
|- CONTACT for SCIENTIFIC QUERIES|| Rozemarije Holewijn|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Currently the standard Deep Brain stimulation (DBS) in Parkinson's (PD) performed under local anesthesia Unfortunately the procedure is very burdensome for patients. Due to advances in modern imaging techniques, it is now possible to visualize the DBS-target directly. Surgery for DBS could therefore be performed under general anesthesia.
The primary objective is to optimize the current DBS-treatment of advanced PD. For the primary objective the following research question will be answered: by performing subthalamic nucleus (STN) DBS under general anesthesia, will there be a significant reduction in cognitive, mood and behavioral adverse effects when compared to STN DBS under local anesthesia?
Secondary objectives are to compare motor symptoms, adverse effects and complications, surgery time, functional health, quality of life, patient satisfaction on the outcome of treatment, and patient evaluation of the burden of therapy.
This study is a single center prospective randomized open label blinded endpoint study. 110 patients with advanced PD with an indication for DBS will be included. The follow-up period will be 6 months.
This study will contribute to reducing the burden of DBS surgery. If DBS surgery under general anesthesia is shown to produce less cognitive, mood and behavioral adverse effects compared to surgery under local anesthesia, this would significantly lower the risk of side effects associated with local anesthesia.
Recruiting countries: The Netherlands
|- Main changes (audit trail)|
|- RECORD||1-apr-2016 - 22-jun-2016|